Identifiers
Functions
Regulatory treatment of Zein varies by market and product category. In the EU, Zein is an active cosmetic ingredient with functions as a film former, hair conditioner, and skin conditioner, with no specific restrictions or maximum concentration limits listed. In the US, Zein is not directly regulated, but its constituent amino acid, L-glutamic acid, is permitted as a food additive for direct addition to food, subject to good manufacturing practices and functional effect limits. For pesticide uses, L-glutamic acid is exempt from tolerance requirements on all food commodities when used per good agricultural practices. In Australia and New Zealand, L-glutamic acid is listed on industrial chemical inventories, with New Zealand allowing use under group standards rather than individual approvals.
6 regulations
L-Glutamic acid is listed on the EPA's Chemical Data Reporting (CDR) system. Manufacturers and importers of L-Glutamic acid are required to report information about their production and use of this chemical to the EPA under the Toxic Substances Control Act (TSCA). (40 eCFR Part 711)
Residues of L-glutamic acid are exempted from the requirement of a tolerance when used in accordance with good agricultural practice as inert (or occasionally active) ingredients in pesticide formulations applied to growing crops only. Use: Plant nutrient. Limit: Seed treatment use only.
Sources
Regulatory records
| Entry | Regulation | Type | Status | Source |
|---|---|---|---|---|
| 182.1045 | 21 CFR 182.1045 | Food Additive | authorized | View |
Regulatory records
| Entry | Regulation | Type | Status | Source |
|---|---|---|---|---|
| 172.320 | 21 CFR 172.320 | Food Additive | authorized | View |
Glutamic acid is a non-essential amino acid and an excitatory neurotransmitter; Used as a nutritional supplement; [Merck Index] Active product registrations in the US for use as a crop growth enhancer (increases yield, size and/or quality, etc.); [NPIRS] Used as a flavoring agent, nutritional supplement, and pH control agent for foods; [FDA] Permitted for use as an inert ingredient in non-food pesticide products; [EPA]
Regulatory records
| Regulation | Status |
|---|---|
| FDA Technical Effect: FLAVORING AGENT OR ADJUVANT | authorized |
| FDA Technical Effect: NUTRIENT SUPPLEMENT | authorized |
| FDA Technical Effect: PH CONTROL AGENT | authorized |
3 regulations
Status: Active Update: 31-03-2023 https://echa.europa.eu/registration-dossier/-/registered-dossier/12560
Regulation (EC) No 1333/2008 (amended)
Regulation (EC) No 1333/2008 (amended)
1 regulation
Regulatory records
| Entry | Regulation | Type | Status |
|---|---|---|---|
| 56-86-0 | SOR/94-311 | DSL | authorized |
Conditions
This substance is on the Domestic Substances List (DSL). This substance was added to the DSL as an “Existing Substance” given that it meets the criteria set out in CEPA for substances that were in commerce in Canada between 1984 and 1986.
Record details
1 regulation
Regulatory records
| Entry | Regulation | Type | Status |
|---|---|---|---|
| 8235 | Inventory of Existing Cosmetic Ingredients in China (IECIC) I | List I | authorized |
Record details
1 regulation
Chemical: L-Glutamic acid
1 regulation
L-Glutamic acid: Does not have an individual approval but may be used under an appropriate group standard
For Zein, the most relevant conditions and limits are those applied to its constituent L-glutamic acid. In food use, the quantity added must not exceed the amount reasonably required to achieve its intended technical effect, and the substance must be of food grade. For pesticide applications, L-glutamic acid is exempt from tolerance requirements when used as an inert ingredient in accordance with good agricultural practices, with a specific limit for seed treatment use only. In cosmetics, Zein has no listed restrictions or maximum concentration limits. GHS classifications for L-glutamic acid indicate hazards for skin corrosion and serious eye damage, which may affect handling and labeling requirements.
Before launching a product containing Zein, ensure the following are in place: For food applications, confirm that Zein or its components meet FDA food additive requirements, including that the quantity used does not exceed the amount needed for the intended technical effect and that the ingredient is of appropriate food grade. For pesticide products, verify that L-glutamic acid is used as an inert ingredient per FIFRA exemptions and good agricultural practices. For cosmetics, confirm Zein's active status in the EU with no restrictions, and ensure compliance with any applicable ozone-depleting substance bans. Additionally, review GHS classifications for handling and labeling, and check TSCA commercial activity status for US manufacturing or import.
The available regulatory position stops short of providing Zein-specific approvals or restrictions. Most evidence pertains to L-glutamic acid, a component, not Zein itself. For food use, while L-glutamic acid is permitted, there is no explicit GRAS or food additive status for Zein. In cosmetics, Zein is listed as active with no restrictions, but this does not confirm safety for all product types or concentrations. For pesticide uses, exemptions apply to L-glutamic acid, not necessarily to Zein as a whole. Additionally, GHS classifications for L-glutamic acid may not reflect Zein's hazard profile. Therefore, a decision on Zein requires additional ingredient-specific data.
No recent regulatory changes or effective dates specific to Zein were identified in the supplied evidence. The EU REACH registration for L-glutamic acid was updated on 31 March 2023, indicating active status. For cosmetics, Zein is listed in the EU with an active status and no restrictions, but no recent amendments were noted. In the US, TSCA commercial activity status for L-glutamic acid is active, but no changes were reported. Therefore, no material regulatory changes affecting Zein are evident from the current data.